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Update on the Nine CMS-NCI Sponsored Clinical Trials of Four Colorectal Drugs: Progress Is Slow, Accrual Not Completed
On September 20 and 21, 2005, the National Cancer Advisory Board convened in Bethesda, Maryland, to discuss a number of issues, including the status of the Centers for Medicare and Medicaid Services (CMS) and National Cancer Institute (NCI) Oncology Pilot Project.
Under a national coverage decision (NCD) issued on January 28, 2005, CMS will cover the “clinical and experimental” costs of oxaliplatin (Eloxatin™), irinotecan (Camptosar�), cetuximab (Erbitux™), or bevacizumab (Avastin™) in nine NCI-sponsored clinical trials evaluating their use in off-label indications—recently referred to as the Oncology Pilot Project. These selected trials study one or more off-label uses of these drugs in colorectal cancer and in other cancer types in order to collect and validate clinical evidence to use new therapies most effectively.
Slow progress is being made. Almost ten months after announcement of the NCD, the nine trials identified by NCI have yet to begin. According to Mark Clanton, MD, MPH, NCI Deputy Director for Cancer Care Delivery Systems, the six colorectal and three non-colorectal NCI/CMS collaborative clinical trials were selected for launch due to the treatment’s high levels of off label usage and its perplexing irregularities for researchers.
Dr. Clanton indicated that the partnership between NCI and CMS is intended to explore how the two agencies can align their resources and agency-specific goals to accelerate development of evidence for emerging cancer treatment regimens. He further suggested that “this can be done by having CMS collect data to make reasonable and necessary determinations for off-label cancer treatments while NCI sponsors trials as part of a research agenda to evaluate use of new agents in off-label indications to determine safety and efficacy.”
What’s in it for the agencies? CMS lacks the statutory authority to conduct research, and views the Oncology Pilot Project as an opportunity to reach its goal of becoming more evidence based. By contrast, NCI views these clinical trials as an opportunity to advance the knowledge for these agents as well as to serve as a potential model for additional coverage expansions in clinical trials for other anti-cancer agents by both CMS and other insurance carriers.
Don Jewler, Communications Director
